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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004228
Receipt No. R000005083
Scientific Title Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients
Date of disclosure of the study information 2010/10/31
Last modified on 2012/03/17

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Basic information
Public title Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients
Acronym HT for swallowing reflex and prevention of pneumonia in brain disease
Scientific Title Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients
Scientific Title:Acronym HT for swallowing reflex and prevention of pneumonia in brain disease
Region
Japan

Condition
Condition post cerebrovascular disease, neurodegenerative diseases e.g. PD, SCD, ALS
Classification by specialty
Medicine in general Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of BHT for swallowing refles disorder and preventing aspiration pneumonia in brain disease patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes wallowing reflex, pneumonia onset
Key secondary outcomes days with fever over 37.5, self-feeding

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Taking BHT (traditional Chinese medicine) 8weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.elderly patients with brain diseases
2.Swallowing reflex can be tested
3.Aspiration pneumonia history at least 1 time
4.Transaminases are less than twice of w.n.l.
5.Cre less than 2.0
6.Stable status and will survive more than 3 months after baseline
7.With informed concent and agreement from patients or family members
Key exclusion criteria 1.Patients having malignancy, severe heart diseases and other factors that would influence the results.
2.Chronic respiratory diseases e.g. BA, COPD
3.Without agreement of patients or family members
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Takemoto
Organization Tagami memorial hospital
Division name Internal medicine
Zip code
Address Nisibeppucho 1779, Kagoshima City
TEL 099-282-0051
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Takemoto
Organization Tagami memorial hospital
Division name Internal medicine
Zip code
Address Nisibeppucho 1779, Kagoshima City
TEL 099-282-0051
Homepage URL
Email yoshinobu_takemoto@shunpukai.com

Sponsor
Institute Dept. of traditional Asian medicine, Postgraduate school of medicine, Tohoku University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Yonezawa hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Tagami memorial Hospital, Kagoshima Prefacture, National Yonezawa hospital, Yamagata Pref

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jglobal.jst.go.jp/public/20090422/201102220184329522
Number of participants that the trial has enrolled
Results 
Hangekobokuto improved the swallowing refex and decrease the pneumonia onset.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 17 Day
Last modified on
2012 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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